Congress Topics

Topics to be covered in CTMD 2016

  • How do clinical trials protect participants?
  • Clinical Research Versus Medical Treatment
  • New horizons – clinical trial in BRIC countries, Israel and Mexico
  • The new EU MDR and the impact on clinical evidences
  • Clinical trials - Regulation EU No 536/2014
  • US Fast Track for unmet clinical conditions
  • Mutual recognition between countries - clinical outcomes
  • The importance of literature review, dos and don'ts

    Design the Best Study
    • Choose the best end point study that provides answers and that has a high probablilty of achievement
    • Design studies that provide high quality data and can be used for decision making 
    • Include criteria that enable fast recruitment of patients;  Choose design elements and inclusion/exclusion criteria that increase the probability of success for the study
    • Ensure the best retention rate

     Improve Regulatory Process; Better understanding of how to collaborate with regulatory authorities

    • Help the regulatories develop a fast track approval for clinical studies on all levels (EMA/FDA, Country level, Institute level)
    • Encourage off label to label studies 
    • Enable collaboration between regulatories, payers, industry and academia, to ensure high probability of successful drug marketing

    Involvement of Digital Medicine

    • Design RCT’s using electronic charts
    • Use electronic chart to study real world efficacy and safety of drugs and device

    Power Post-Marketing Surveillance
    • Ensure Proper Data Collection
    • Improve Critical AE reporting